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Sponsors and Collaborators: |
Novartis Novartis Vaccines |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00450437 |
This study will evaluate the lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.
Condition | Intervention | Phase |
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Meningococcal Disease Meningococcal Meningitis |
Biological: Novartis Meningococcal ACWY Conjugate Vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Multi-Center Study to Evaluate Lot to Lot Consistency, Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults and Compare to the Safety and Immune Response to a Licensed Conjugate Meningococcal ACWY Vaccine |
Estimated Enrollment: | 3000 |
Study Start Date: | March 2007 |
Ages Eligible for Study: | 11 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Birmingham, Alabama, United States, 35205 | |
Birmingham, Alabama, United States, 35244 | |
Tuscaloosa, Alabama, United States, 35487-0326 | |
United States, California | |
Oakland, California, United States, 94612 | |
Sacramento, California, United States, 95817 | |
United States, Colorado | |
Denver, Colorado, United States, 80218 | |
United States, Georgia | |
Marietta, Georgia, United States, 30062 | |
Woodstock, Georgia, United States, 30189 | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Chicago, Illinois, United States, 60614-3394 | |
United States, Maryland | |
Frederick, Maryland, United States, 21702 | |
Annapolis, Maryland, United States, 21401 | |
United States, Massachusetts | |
Boston, Massachusetts, United States, 02118 | |
Fall River, Massachusetts, United States, 02124 | |
United States, New Hampshire | |
Lebanon, New Hampshire, United States, 03756 | |
United States, Ohio | |
Akron, Ohio, United States, 44308 | |
Cleveland, Ohio, United States, 44118 | |
Cincinnati, Ohio, United States, 45229 | |
United States, Pennsylvania | |
Pittsburgh, Pennsylvania, United States, 15241 | |
Sellersville, Pennsylvania, United States, 18960 | |
Harleyville, Pennsylvania, United States, 19438 | |
United States, Texas | |
Galveston, Texas, United States, 77555-0371 | |
United States, Washington | |
Seattle, Washington, United States, 98101-1466 |
Study Chair: | Novartis Vaccines - Information Services | Novartis |
Study ID Numbers: | V59P13 |
Study First Received: | March 21, 2007 |
Last Updated: | April 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00450437 |
Health Authority: | United States: Food and Drug Administration |
Meningococcal meningitis vaccine adolescents adults |
Bacterial Infections Central Nervous System Infections Meningococcal Infections Meningitis, Bacterial Meningitis, Meningococcal |
Central Nervous System Diseases Meningococcal infection Gram-Negative Bacterial Infections Neisseriaceae Infections Meningitis |
Nervous System Diseases Central Nervous System Bacterial Infections |